Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 12:14 PM
Study NCT ID:
NCT07115134
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates Gastrostomy Tube Dislodgement Before and After Dressing Placement', 'timeFrame': 'Up to one year', 'description': 'Current rates of gastrostomy tube complications and dislodgement will be evaluated with our retrospective review, then compared to rates of complications and dislodgement after our novel dressing placement. This was chosen as complications after gastrostomy tube placement are high, and we believe that our dressing will lower them.'}, {'measure': 'Gastrostomy tube complications', 'timeFrame': 'Up to one year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gastroenterology Surgery', 'Tube Feeding']}, 'descriptionModule': {'briefSummary': "This is a single-center prospective study evaluating the efficacy of a prototype gastrostomy anchor dressing for use with button gastrostomy tubes. The anchor dressing has been previously evaluated for usability by parents, patients, and nurses. This study compares several outcomes related to complications from gastrostomy tube placement using a prospective cohort of patients and a retrospective analysis of complications associated with gastrostomy tubes. Prospective patients will initially be monitored until they have completed their last dressing change or for a maximum of 50 days. They will then complete their final survey. Their charts will be reviewed for up to one year from their initial gastrostomy placement. The study's primary objective is to determine if the novel gastrostomy tube anchor dressing reduces rates of gastrostomy tube dislodgement and ED/clinic visits for gastrostomy tube complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are undergoing gastrostomy tube placement or are within five days post-operatively of gastrostomy tube placement.\n\nExclusion Criteria:\n\n* 1\\. Patients with a skin condition that limits the placement of the dressing, this will be confirmed with the clinical team'}, 'identificationModule': {'nctId': 'NCT07115134', 'acronym': 'Tube Anchor', 'briefTitle': 'Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing', 'organization': {'class': 'OTHER', 'fullName': "Children's National Research Institute"}, 'officialTitle': 'Efficacy of a Novel Prototype Gastrostomy Tube Anchor Dressing', 'orgStudyIdInfo': {'id': 'STUDY00001158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bearables Gastrostomy Tube Dressing Prototype', 'interventionNames': ['Device: Bearables Gastrostomy Tube Dressing']}], 'interventions': [{'name': 'Bearables Gastrostomy Tube Dressing', 'type': 'DEVICE', 'description': 'The gastrostomy tube dressing in its current design is composed of two parts, both of which are external to the patient: one part is rigid and holds the gastrostomy at a fixed position, this is a 3D printed design that is produced here. The second part is a 3" x 3" flexible, cushioned, biocompatible adhesive bandage designed to fit around the skin opening (Silicone Foam Dressing, NH NeuHeils, USA). The design is subject to minor changes including the number of parts and location with the structure of the padding and securement but will continue to be designed with comfort as a priority. After assembly, the device is packaged (sterilization pouches, Plastcareusa, USA), sealed, and sanitized using UV light prior to patient use.', 'armGroupLabels': ['Bearables Gastrostomy Tube Dressing Prototype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Anthony Sandler', 'role': 'CONTACT', 'email': 'asandler@childrensnational.org', 'phone': '202-476-5760'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's National Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}